STA-R MAX 59012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-07-22 for STA-R MAX 59012 manufactured by Diagnostica Stago S.a.s..

MAUDE Entry Details

• Report Number: 8043273-2019-00007
• MDR Report Key: 8811851
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-07-22
• Date of Report: 2019-05-15
• Date of Event: 2019-04-02
• Date Facility Aware: 2019-07-16
• Report Date: 2019-07-22
• Date Reported to FDA: 2019-07-22
• Date Mfgr Received: 2019-05-15
• Device Manufacturer Date: 2018-05-31
• Date Added to Maude: 2019-07-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. WALID BEN AMMAR
• Manufacturer Street: 2 RUE PIERRE FOSSATI
• Manufacturer City: FRANCONVILLE, 95130
• Manufacturer Country: FR
• Manufacturer Postal: 95130
• Manufacturer G1: DIAGNOSTICA STAGO S.A.S.
• Manufacturer Street: 3 ALL
• Manufacturer City: ASNI 92600
• Manufacturer Country: FR
• Manufacturer Postal Code: 92600
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STA-R MAX
• Generic Name: IVD COAGULATION DEVICE/INSTRUMENT
• Product Code: JPA
• Date Received: 2019-07-22
• Model Number: 59012
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1 YR
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DIAGNOSTICA STAGO S.A.S.
• Manufacturer Address: 3 ALL?E TH?R?SA ASNI?RES-SUR-SEINE, 92600 FR 92600

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-07-22